Emma Harvey is global head of medical affairs at F2G Ltd, a UK and Austria based biotech where she is responsible for the global medical and commercial strategies for a novel antifungal drug for serious systemic infections, in clinical development.
CDMO Sterling Pharma Solutions has been granted a Manufacturer’s Authorisation for Investigational Medicinal Products from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
The UK Medicines and Healthcare products Regulatory Agency (MHRA) will receive £10m ($12m) in extra government funding over the next two years: targeted at helping the agency adapt post-Brexit and accelerating routes for bringing new medicines onto the...
The new Clinical Biotechnology Centre (CBC) in Bristol will expand the UK’s ability to make clinical grade products for the research and development of new cell and gene therapies.
Biotage will acquire Astrea Bioseparations, a chromatography solutions provider, from Gamma Biosciences: extending its chromatography franchise into the bioprocessing market for biologics and advanced therapeutic customers.
Gilead’s CAR-T therapy Yescarta (Axicabtagene ciloleucel) has been recommended for routine use on the National Health Service (NHS) in England for patients with an aggressive form of lymphoma.
BioNTech and the UK government have signed a wide-reaching Memorandum of Understanding (MoU): with one of the goals to provide up to 10,000 patients with personalized mRNA cancer immunotherapies by 2030.
Apollo Therapeutics and The Institute of Cancer Research in London have entered into a strategic collaboration to discover and develop new cancer medicines.
AbbVie will acquire DJS Antibodies Ltd, a privately-held UK-based biotechnology company dedicated to discovering and developing antibody medicines that target difficult-to-drug disease-causing proteins.
The Coalition for Epidemic Preparedness Innovations (CEPI) will provide funding of up to $375,000 to the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the UK Health Security Agency (UKHSA) to support the development of laboratory tools...
A new type of vaccine - which could provide broad protection against a variety of SARS-like betacoronaviruses, including SARS-CoV-2 variants - has received backing of up to $30m from CEPI.
RQ Biotechnology is launching as a new UK-based biotech: following the completion of a successful licensing deal with AstraZeneca for early-stage monoclonal antibodies targeted against SARS-CoV-2.
The Cell and Gene Therapy Catapult (CGT Catapult) has today published the ‘National Cell and Gene Therapy Vision for the UK’, a document outlining recommendations for a national strategy for the adoption of cell and gene therapies.
Valneva has been awarded up to £20m ($27m) in R&D funding from Scottish Enterprise: which will be used to revive its plans to increase vaccine manufacturing in Scotland.
CDMO Piramal Pharma Solutions will expand capabilities of its Antibody-Drug Conjugate (ADC) facility in Grangemouth, Scotland; and invest in new Active Pharmaceutical Ingredient (API) infrastructure at its Morpeth, England facility.
Last year was the highest year on record for investments into UK biotech and life science companies: with £4.5bn ($6bn) raised in public and private financings, representing 60% more than in 2020.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation to improve and strengthen UK clinical trials legislation.
The UK government accuses Valneva of being in breach of its supply agreement obligations - something the company 'strenuously denies' - as it cancels its COVID-19 vaccine contract.
Vaccitech has signed a lease for 31,000 sq. ft at Harwell Science and Innovation Campus in the UK, fitting out the facility with a state-of-the art wet laboratory and offices.
The antibody response in people aged 80+ is three and a half times greater when the second dose of the COVID-19 vaccine is administered after 12 weeks, compared to the response when the second dose is given after three weeks, according to a UK study....
The Medicines and Healthcare products Regulatory Agency (MHRA) has published final guidance on how the UK will license biosimilar products now it is outside of the European Union.
The UK’s Joint Committee on Vaccination and Immunisation (JCVI) says that pregnant women should be offered either the Pfizer/BioNTech or Moderna COVID-19 vaccines.
Valneva will take its COVID-19 vaccine candidate into a Phase 3 clinical trial this month, following positive Phase 1/2 data for the inactivated, adjuvanted vaccine.
The UK has a strong genetics research base: but to date, academics have found it difficult to progress gene therapy research into clinical trials and beyond. The Sheffield Gene Therapy Innovation and Manufacturing Centre (GTIMC) is one of three new hubs,...
The British Medical Association (BMA), the trade union and professional body for doctors in the UK, is calling for the delay between Pfizer/BioNTech COVID-19 vaccine doses to be reduced from 12 weeks to six weeks.
The World Health Organization’s vaccine advisory group recommends the two doses of the Pfizer/BioNTech vaccine should be delivered 21 to 28 days apart: although it adds that the maximum time period between doses could be up to six weeks in some situations.
More than 360,000 people have signed up to the UK’s registry of people interested in participating in vaccine trials: the world’s first database of its kind. The UK is also exploring other measures – such as human challenge trials - to boost clinical...
Valneva has started a Phase 1/2 trial of its COVID-19 vaccine: eying up potential regulatory approval in the fourth quarter of 2021. It champions a ‘tried and tested’ approach with its inactivated candidate.
The UK’s MHRA says anyone with a history of anaphylaxis should not receive the Pfizer/BioNTech COVID-19 vaccine: following two reports of anaphylaxis and one report of a possible allergic reaction in the first immunizations carried out this week.
The UK is set to begin COVID-19 human challenge trials in January: aiming to increase understanding of coronavirus and speed up development of vaccine candidates.
AstraZeneca has resumed UK clinical trials for its Oxford coronavirus vaccine, having paused all trials last week for a safety review. Other late-stage global trials, however, remain on hold while AstraZeneca waits for regulators in each market.
Year-on-year, the number of trials for advanced therapeutics has doubled, meaning that the UK now represents 12% of all global clinical trials in the area.
With the number of roles in manufacturing projected to rise by 196% over the next five years, industry fears a lack of expertise to fill vacuum, according to survey.
CGT Catapult adds six additional clean room spaces to its Stevenage manufacturing center, to aid companies readying themselves for clinical and commercial manufacture.
UK government invests further in businesses manufacturing advanced therapies, opening a fund for companies working on technology to improve commercial production.
